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Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

December 30, 2019


This study aims to investigate the efficacy of the drug crofelemer in preventing diarrhea in patients who have chemotherapy for breast cancer. Diarrhea presents in 40-80% of patients undergoing chemotherapy for HER2 positive locally advanced or metastatic breast cancer. While there are drugs and agents that treat diarrhea, none are specifically studied to target chemotherapy induced diarrhea.


Study Information

In this study, investigators will split the 52 participants into experimental and control groups. The experimental group will receive one tablet of crofelemer to be taken orally twice a day during the first two cycles of chemotherapy and then monitored during the 3rd cycle. The control arm will not receive crofelemer.


Inclusion Criteria


  • Willing and able to provide written informed consent
  • Men and women ≥18 years of age
  • Pathologically confirmed diagnosis of HER2 positive breast cancer of any stage (previous treatment is allowed without limits on lines of prior therapy)
  • Scheduled to receive at least 3 consecutive cycles of THP or TCHP
  • Performance status of 0-2 according to the ECOG scale
  • Negative pregnancy test at time of informed consent for women of childbearing potential;
  • Able to read, understand, follow the study procedure and complete crofelemer, rescue medication, and bowel movement diaries
  • Patients may enroll simultaneously on this study and other studies, including but not limited to NSABP B52
  • Patients with brain metastases (including concurrent steroid treatment) are allowed on this study.
  • Left Ventricular Ejection Fraction (LVEF) greater or equal to 50% at baseline as determined by either ECHO or MUGA


Exclusion Criteria


  • Pregnant and/or breastfeeding
  • Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn’s disease, microscopic colitis, etc.)
  • Use of investigational drugs within 3 weeks of signing consent or foreseen use during the study
  • Use of chemotherapy, trastuzumab, or pertuzumab within the past 3 weeks;
  • Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotics for procedures including, but not limited to port placement, is permitted)
  • Any type of ostomy
  • Total colectomy
  • Fecal incontinence
  • Ongoing radiation induced diarrhea or constipation or planned radiotherapy to the abdomen or pelvis while on study
  • Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, antifungals, anti-parasites, anti-virals
  • Abdominal or pelvic surgery without recovery of bowel function
  • Inadequate organ function for starting THP or TCHP, which may include the following laboratory results within 28 days prior to signing consent:
  1. Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)
  2. Serum creatinine > 2.0 mg/dL or 177 μmol/L
  3. AST (SGOT) and ALT (SPGT) > 2.5 ULN.



Lombardi Comprehensive Cancer Center

Washington, District of Columbia, United States, 20007

Contact: Ann Gallagher, MS    202 687-3981  

Contact: Julie Castle, RN, BSN, OCN    202-687-2209  

Principal Investigator: Sandra M Swain, MD, FACP, FASCO        

Principal Investigator: Paula R Pohlmann, MD, PhD        

Sub-Investigator: Jennifer J Gao, MD


MedStar Franklin Square Cancer Center at Loch Raven Campus

Baltimore, Maryland, United States, 21218

Contact: Barbara Rector, RN    410-261-8151  

Principal Investigator: Mahsa Mohebtash, MD        


Harry and Jeanette Weinberg Cancer Institute

Baltimore, Maryland, United States, 21237

Contact: Yvonne Ottaviano, MD    443-777-7147      

Principal Investigator: Yvonne Ottaviano, MD        


John Theurer Cancer Center at Hackensack Univ

Hackensack, New Jersey, United States, 07601

Contact: Deena Graham, MD    551-996-5811  



Georgetown University

Lombardi Comprehensive Cancer Center

Medstar Health Research Institute

Genentech, Inc.

Napo Pharmaceuticals, Inc.

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